Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
TAMSULOSIN HYDROCHLORIDE (UNII: 11SV1951MR) (TAMSULOSIN - UNII:G3P28OML5I)
Macleods Pharmaceuticals Limited
TAMSULOSIN HYDROCHLORIDE
TAMSULOSIN HYDROCHLORIDE 0.4 mg
ORAL
PRESCRIPTION DRUG
Tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension. Tamsulosin hydrochloride capsules are contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of tamsulosin hydrochloride capsules. Reactions have included skin rash, urticaria, pruritus, angioedema, and respiratory symptoms [see Adverse Reactions (6.2)]. Risk Summary Tamsulosin hydrochloride is not indicated for use in women. There are no adequate data on the developmental risk associated with the use of tamsulosin hydrochloride in pregnant women. No adverse developmental effects were observed in animal studies in which tamsulosin hydrochloride was administered to rats or rabbits during the period of organogenesis (GD 7 to 17 in the rat and GD 6 to 18 in the rabbit) [see Data]. In the U.S. general population, the e
Tamsulosin hydrochloride capsules, USP are comprising of olive green opaque cap imprinted “CL 23", and orange opaque body imprinted "0.4" in black ink. Tamsulosin hydrochloride capsules, USP 0.4 mg are supplied as below: Bottle of 30 capsules NDC 33342-159-07 Bottle of 100 capsules NDC 33342-159-11 Bottle of 500 capsules NDC 33342-159-15 Bottle of 1000 capsules NDC 33342-159-44 Unit dose package of 100 capsules NDC 33342-159-12 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep tamsulosin hydrochloride capsules and all medicines out of reach of children.
Abbreviated New Drug Application
TAMSULOSIN HYDROCHLORIDE - TAMSULOSIN HYDROCHLORIDE CAPSULE MACLEODS PHARMACEUTICALS LIMITED ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TAMSULOSIN HYDROCHLORIDE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TAMSULOSIN HYDROCHLORIDE CAPSULES. TAMSULOSIN HYDROCHLORIDE CAPSULES, FOR ORAL USE INITIAL U.S. APPROVAL: 1997 INDICATIONS AND USAGE • Tamsulosin hydrochloride is an alpha adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia (1) • Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension (1) DOSAGE AND ADMINISTRATION • 0.4 mg once daily taken approximately one-half hour following the same meal each day. Tamsulosin hydrochloride capsules should not be crushed, chewed or opened. (2) • Can be increased to 0.8 mg once daily for patients who fail to respond to the 0.4 mg dose after 2 to 4 weeks of dosing (2) • If discontinued or interrupted for several days, therapy should start again with the 0.4 mg once-daily dose (2) DOSAGE FORMS AND STRENGTHS • Capsules: 0.4 mg (3) CONTRAINDICATIONS • Contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of tamsulosin hydrochloride capsules (4, 6.2) WARNINGS AND PRECAUTIONS • Advise patients about the possibility of symptoms related to postural hypotension and to avoid situations where injury could result should syncope occur (5.1) • Should not be used in combination with strong inhibitors of CYP3A4. Use with caution in combination with moderate inhibitors of CYP3A4, with strong or moderate inhibitors of CYP2D6, in patients known to be CYP2D6 poor metabolizers, or in combination with other cytochrome P450 inhibitors. (5.2, 7.1, 12.3) • Should not be used in combination with other alpha adrenergic blocking agents (5.2, 7.2, 12.3) • Exercise caution with concomitant administration of warfarin (5.2, 7.4, 12.3) • Advise patients about the Прочетете целия документ